FDA Increases Oversight of Lab Tests to Enhance Accuracy and Safety

The Food and Drug Administration (FDA) has finalized a new regulation that will require makers of medical tests to show that their new offerings deliver accurate results. This rule, which has been vigorously opposed by the testing industry, aims to gradually phase in oversight of new tests developed by laboratories to ensure that tests for various illnesses are safe, accurate, and reliable.

FDA commissioner Robert Califf stated that the goal of the new rule is to provide crucial oversight of these tests to ensure that important healthcare decisions are made based on trustworthy test results. Inaccurate tests can lead to unnecessary treatment or delays in getting proper care, highlighting the importance of this regulation.

Under the government’s plan, newly developed tests that pose a high risk will need to be FDA approved within 3 1/2 years, while lower-risk tests will have four years to obtain approval. However, the FDA decided that the tens of thousands of tests currently on the market will not have to undergo federal review, essentially grandfathering them into approval to prevent the loss of access to beneficial tests.

The industry has resisted additional scrutiny for decades, arguing that it will stifle innovation and increase costs. With an estimated 80,000 medical tests currently available from about 1,200 labs, the new regulation will have a significant impact on the testing industry and the healthcare system as a whole.